Improving the Reach & Effectiveness of Smoking Cessation Services Targeted to Veterans Living With HIV — WISH  

HIV Infections Clinical Trial

Official title: Improving the Reach and Effectiveness of Smoking Cessation Services Targeted to Veterans Living With HIV

Status Recruiting

Clinical Trial Summary

This project will compare the effectiveness of an HIV-specific comprehensive wellness intervention designed to have broad appeal to smokers living with HIV to the effectiveness of standard care services that include referral to the National VA Quitline and SmokefreeVET texting program. Participants in both arms will have access to pharmacotherapy available through their Veterans Affairs (VA) healthcare providers.

Clinical Trial Description

Tobacco use remains the leading preventable cause of death and illness in our society, and smoking rates are disproportionately high among people living with HIV. NCI, nicotine dependence researchers, and HIV clinicians have all called for research to evaluate targeted and tailored smoking cessation programs for smokers living with HIV (SLWH). Research suggests SLWH are largely unaware of the HIV-specific deleterious effects of smoking and often lack motivation and confidence in their ability to quit. For these reasons, we developed the Wellness Intervention for Smokers with HIV (WISH).

Similar to standard care cessation services available to Veterans, WISH is delivered remotely by mobile phone (voice and text message). The program is designed for all SLWH, regardless of their initial motivation to quit. WISH follows evidence-based, best practice guidelines for nicotine dependence treatment, but is innovative in its use of a more comprehensive wellness approach. That is, the intervention addresses both smoking and a number of other personally relevant health behaviors (such as treatment engagement, medication adherence, stress and mood management, social support, alcohol use, etc.), making it relevant and engaging to all SLWH, not just those ready to stop smoking. For those not yet ready to quit, WISH is designed to build and strengthen motivation and self-confidence for quitting, while smokers also work on other personal health goals.

Once ready to quit smoking, participants receive evidence-based cognitive-behavioral counseling and encouragement to access nicotine replacement therapy (NRT) or other appropriate pharmacotherapy through usual care VA procedures. Medications will not be prescribed or dispensed by the study, allowing use of these standard services to be compared across study groups.

In this two-group randomized trial, we will compare the effectiveness of WISH to standard care services offered through the National VA Quitline and the SmokefreeVET texting program (tobacco cessation services available to all Veterans). Participants in both study groups can receive phone/ text counseling and have access to pharmacotherapy through VA. Cessation services in both study groups will be provided and overseen by the non-VA sites that developed each program.

Smoking-related outcomes will include 7-day point prevalence smoking abstinence and presence of any 24-hour intentional quit attempts, prolonged abstinence, and change in cigarettes per day. We will measure change in smoking-related knowledge, motivation and behavioral skills, as well as intervention reach and implementation. We will also describe comorbidities and explore intervention impact on markers of immune status and mortality risk using clinical data resources available through the Veterans Aging Cohort Study (VACS).

If effective, WISH could meaningfully increase the reach of cessation services and reduce smoking among HIV+ Veterans nationwide. To support this goal, dissemination efforts are planned in Year 5 to share the WISH program with the National VA Quitline. Because VA is the largest U.S. provider of HIV care, this research has the potential for significant public health impact. ;

Related Conditions & MeSH terms

• HIV Infections
• Smoking
• Smoking Cessation

• NCT number: NCT04505371
• Study type: Interventional
• Source: Seattle Institute for Biomedical and Clinical Research
• Contact: John Kundzins, BS
• Phone: (206) 268-5278
• Email: John.Kundzins@VA.gov
• Status: Recruiting
• Phase: N/A
• Start date: June 4, 2021
• Completion date: August 31, 2025